As the world emerged from the height of the COVID-19 crisis, many laboratories found themselves equipped with state-of-the-art instruments, expanded staff, and new testing infrastructure—but lacking the validation expertise to pivot to a sustainable, post-pandemic testing model. Dr. William Budd, a seasoned molecular diagnostics expert, witnessed this gap first-hand. Recognizing that most consulting firms had simply chased the pandemic boom—then left labs to fend for themselves—Dr. Budd set out to build something different. He founded Alliant Lab Consulting specifically to guide clinical and physician office laboratories through that critical transition. “We wanted to become the one-stop solution for clinical laboratories and physician office laboratories,” Dr. Budd explains, “to get them up and running quickly so they could continue offering services and remain profitable after making significant investments during the pandemic.” From day one, Alliant has stood apart by pairing deep regulatory expertise (CAP, CLIA, COLA, JCAHO) with a vendor-agnostic approach. Instead of recommending a single manufacturer’s platform, they customize analytical and clinical validation plans to match each lab’s existing equipment and business goals. Alliant Lab Consulting has rapidly established itself as a leader in laboratory innovation solutions. Today, the firm not only validates infectious disease testing such as respiratory pathogen panels and urinary tract infection assays but has also expanded into pharmacogenomics, next-generation sequencing, and enterprise-level compliance and revenue cycle services. Its relentless focus on scientific precision and client-centred solutions has propelled Alliant into new realms of clinical testing. Navigating a Fragmented Post-Pandemic Market The post-COVID laboratory marketplace, as Dr. Budd describes, was chaotic and unregulated. The emergency use authorization (EUA) pathway had made it easier for vendors to enter the space during the height of the pandemic. But as COVID case numbers declined and labs sought to diversify their testing portfolios, many found themselves inundated with unsophisticated products from vendors lacking clinical expertise. Some vendors tried expanding their offerings to include assays for conditions like UTIs and respiratory infections. However, their understanding of real-world clinical needs often fell short. While vendors excelled at analytical validation—verifying that an assay worked under ideal lab conditions—they frequently failed at clinical validation, which ensures a test performs reliably in varied, often imperfect, real-world environments.
Therapeutics
Cancer doesn’t discriminate and neither should access to care. A disease that touches millions of lives every year; cancer challenges not just patients, but families, caregivers, and entire communities. Solving for it requires a collective ambition—a global coalition of clinicians, researchers, pharmaceutical leaders, and advocates. In this fast-evolving field, where innovation often outpaces access, BeOne Medicines stands apart: a next-generation global oncology company not just discovering breakthrough treatments, but ensuring they reach the people who need them most. As the oncology landscape expands with scientific advancements, the reality remains: high costs, logistical hurdles, and inequities in healthcare delivery delay lifesaving therapies from reaching large segments of the global population. The company is here to change that equation. Founded in 2010, BeOne has embraced an identity that mirrors its mission. Its name reflects a rallying cry, to BeOne to end cancer. The company is creating the world’s next-generation cancer treatments through relentless innovation and a sustainable business model that leverages cost and time efficiencies to enable better access for patients around the world. With the motto “Cancer has no borders–and neither do we,” the company is pioneering a new era of inclusive, agile and sustainable cancer care - one where geographic borders, socioeconomic status, and outdated clinical trial models no longer dictate a patient’s access to care. For John V. Oyler, co-founder, chairman, and CEO, the company’s strategy is rooted in access and acceleration. “Innovation loses its meaning if it only serves a few. That’s why we built BeOne to do more than discover – we built it to deliver everywhere,” says John V. Oyler, Co-Founder, Chairman & CEO. Building a Company for Global Impact For decades, oncology drug development has been structurally biased toward the wealthiest nations— concentrating clinical trials and commercial launches in the U.S., Europe, and Japan. These markets represent just one-sixth of the world’s eligible cancer patients. The result: a system where the vast majority of people—five-sixths of the global population—are left waiting years to access the most advanced treatments, if they gain access at all. It’s a model driven by the need to recover high development costs in high-return markets. Oyler saw this not only as a moral failure but as a systemic flaw—an entrenched inefficiency that limits both access and innovation. He understood that the rising cost of developing oncology medicines—75 percent of which is spent on clinical trials—was reinforcing global health inequity. As long as trials were concentrated in the U.S., EU, and Japan, companies would be compelled to prioritize those markets alone, entrenching the imbalance. But Oyler also saw a transformative opportunity: by shifting where and how trials are conducted, it was possible to change the cost structure of drug development itself. BeOne believed in building an inclusive clinical trial model that expands beyond traditional geographies to include countries like South Korea, Poland, and Brazil. It wasn’t just about including more countries—it was about building a new operating model that unlocked advantages in cost, speed, and quality, while simultaneously laying the foundation for sustainable access and commercialization in these same markets..
Clinical Laboratory
Breakthroughs in medical and life sciences don’t happen in a vacuum; rather, they require brilliant infrastructure. Top-tier, purpose-built labs are to science what engines are to racing—complex, powerful, and essential. And if that analogy holds, Hankins Consulting is the expert pit crew in the paddock, ensuring each setup is fine-tuned for speed, precision, and performance. The company does it all—from building state-of-the-art laboratories from the ground up to managing daily operations and revitalizing underperforming labs. With over four decades of experience, Hankins Consulting has successfully built more than 70 laboratories and managed countless others. Offering turnkey solutions from concept to operation, the company brings unmatched expertise to every stage of the lab lifecycle. Hankins Consulting’s deep understanding of compliance and regulatory frameworks empowers clients to run streamlined, legally sound, and cost-efficient operations. Beyond operational know-how, it has built an extensive network of partnerships within the laboratory ecosystem. These include biomedical service, revenue cycle management, laboratory information systems, shipping, logistics, and laboratory supplies. Through these trusted partnerships, the company can deliver comprehensive solutions to the clients that often lead to substantial cost savings. “Designing a lab is one thing, but real understanding comes from hands-on experience. Our long-standing industry partnerships and operational knowledge allow us to create efficient, cost-effective labs that are built to perform from day one,” says Ron Hankins, president. Built from the Ground Up-Soup to Nuts Building efficient labs rarely ends with establishing brick and mortar, which is why Hankins Consulting takes a more collaborative approach from the get-go. Whether it’s guiding clients in choosing the right location or managing negotiations, the team ensures every step supports the lab’s long-term goals. And for those with an existing space, Hankins steps in seamlessly to optimize it for both performance and compliance..
Life Science AI
In the life sciences, biotech, and pharm-tech industry, where every day lost can mean millions in delayed revenue, Court Square Group has found a clear mandate to reduce labor-intensive tasks in clinical and regulatory operations using AI. The Massachusetts-based managed service provider has doubled down on AI-enabled solutions that intelligently automate the burdensome tasks slowing drug development, regulatory processes, and clinical documentation. “There is still a lot of hype around AI, and clinical operations groups are looking to understand how to best leverage this rapidly emerging technology to improve operations. We’re not here to force AI into someone’s workflow,” says Keith Parent, founder and CEO. “We’re here to enable clinical professionals to use their time efficiently using AI solutions that reduce manual and repetitive tasks.” The company partners with best-in-class developers to provide AI solutions tailored to each sponsor and CRO’s specific needs. It creates solutions for life sciences clients that bridge technical data science with regulatory and clinical subject matter expertise. By working closely with sponsors and CROs to understand their day-to-day challenges, Court Square Group has earned its reputation as a trusted partner in helping life sciences organizations meet the complex demands of compliance, data integrity, and submission readiness through tailored AI solutions. One such solution is its auto-classification tool for Trial Master File (eTMF) documentation. Sorting tens of thousands of regulatory documents manually can take eight to ten minutes per file, a routine task for clinical trial associates (CTAs) or clinical research associates (CRAs). Court Square Group’s tool classifies documents in any format based on their content to assign the appropriate metadata, saving hours by automating what used to be tedious and repetitive tasks. In higher-confidence scenarios, documents are filed automatically. When confidence is lower, the system proposes a likely classification for human review. Either way, the process shrinks from minutes to seconds. Multiply that out over thousands of documents and they will save weeks if not months worth of time. Intelligent automation is also critical in regulatory submissions and merger and acquisition (M&A) scenarios. For clients acquiring compound data from another organization, thousands of documents must be reviewed and cross-referenced, often manually. Court Square Group deploys an AI-powered utility to scan every file, identify references, and flag missing documents before they become a regulatory issue. What once took weeks is now completed in days. This practical, problem-first approach starts with a question: “What manual efforts are causing the most delays?” That’s how the discussion begins with clients. Instead of letting AI dictate the solution, the team reverse-engineers from the pain points, identifying tasks that drain time but don’t require human judgment. Clients often come in with one automation idea, only to discover five more once their processes are mapped out..
Therapeutics
OncoHost is leading a new era of personalized cancer care, where the patient’s biology, not just the tumor, guides the path forward. For decades, the field has focused almost exclusively on the tumor—its genetic signatures, mutational burden and molecular drivers. But this narrow lens often falls short in predicting real-world treatment outcomes. It overlooks critical biological processes such as immune response, inflammation, and metabolism, factors that significantly influence whether a patient will benefit from therapy. OncoHost brings a disruptive view into the picture, introducing a model that sees the patient not as a passive recipient of care, but as a dynamic biological system whose response can guide the course of treatment. That shift drives the company’s mission to capture cancer’s complexity in the host, not just within the tumor, but across the systemic landscape that defines treatment success or failure. “We believe true precision begins with understanding the full biological context, not just the tumor, but the patient behind it,” says Dr. Ofer Sharon, MD and CEO. At the core of this approach is PROphet®, an AI-driven platform built on advanced proteomics. Using a single blood sample taken before treatment, PROphet® analyzes thousands of plasma proteins to generate a personalized score. This score delivers three key insights: the likelihood of benefit from PD-1/PD-L1 immunotherapy, the biological reason a patient may not respond, and the potential for severe immune-related side effects. The added layer of systemic visibility is what sets PROphet® apart from conventional tumor-centric tools like PD-L1 testing or ctDNA. While those offer static molecular snapshots, PROphet® provides a dynamic, real-time understanding of how the patient’s body is responding to cancer and treatment. It offers not just prediction, but biological explanation, helping oncologists understand why a patient may or may not respond to a particular therapy. The first application of the platform, known as PROphetNSCLC™, supports treatment planning in advanced nonsmall cell lung cancer. The test is designed to complement PD-L1 scoring and existing clinical criteria by introducing a proteomic-based, host biology perspective into the decision-making process. Its clinical utility has been validated through one of the largest prospective trials in immunotherapy and further supported by real-world physician behavior studies..
Antibodies
Failure in clinical trials, diagnostics, and research often starts with a flawed reagent. A slight inconsistency in an antibody conjugate can delay approvals, stall trials, and erase months of progress. Columbia Biosciences aims to prevent that. With deep roots in fluorescent protein purification and a reputation for rescuing projects when others fall short, Columbia Biosciences has become the behind-the-scenes partner powering some of the industry’s most sensitive breakthroughs. Initially focused on isolating and purifying proteins from algae for flow cytometry and immunophenotyping, Columbia Biosciences built a strong foundation in protein science. That foundation led to developing antibody-fluorophore conjugates, setting the stage for a broader bioconjugation service model that includes oligonucleotides, small molecules, and antibody-drug conjugates (ADCs). “We’ve grown by solving tough problems and helping customers scale conjugation with the consistency and quality that are hard to maintain beyond small-scale research,” says John Morseman, CEO of Columbia Biosciences. Meeting the Conjugation Demands of a Rapidly Evolving Market Scientific research and diagnostics increasingly rely on reagents that must perform reliably over time and across varying conditions. A recurring issue for many clients is the struggle to maintain quality while scaling up from labscale experiments to production-level outputs. Columbia Biosciences specializes in helping customers overcome these barriers. One of Columbia Biosciences’ core values is ensuring reproducibility during scale-up—delivering the same reliable performance from early-stage research all the way through clinical trials. Because conjugates must meet rigorous specifications at every step, any failure can bring an entire workflow to a standstill. That is why Columbia Biosciences has engineered its processes to guarantee on-spec conjugates delivered on the demanding timelines today’s researchers require..
Clinical Laboratory
Southwest Labs is tackling New Mexico’s crucial problem head-on. Located in the heart of a state with one of the highest drug overdose deaths, Southwest Labs is overcoming the shortage of local lab services with accurate diagnostics that help combat substance misuse. It addresses two major problems—the growing prevalence of illicit drugs that many labs fail to test for and the diversion of prescribed medications, which adds another layer to the state’s substance misuse issues. Southwest Labs differentiates itself from national mega labs through its adaptability and genuine provider engagement, offering precision diagnostics and a client-first approach to communities that have long lacked these vital resources. Through an extensive test menu, it deals with both illicit drug use and prescription medication misuse. This comprehensive approach allows the lab to provide critical insights to providers, helping them to tackle substance misuse from all angles. “We don’t just address a need, we deliver unmatched speed, precision and personalized service; qualities that larger national labs often lack. Our deep understanding of the community is the driving force behind everything we do,” says Orus Guerra, CEO. From Local Needs to National Relevance This foundation in clinical toxicology led Southwest Labs to develop a broad, dual-focused testing approach, empowering providers with clear, actionable data. The lab’s robust testing capabilities enable providers to quickly identify misuse, reinforce compliance and address evolving clinical and regulatory needs. .
BioTech
Regenerative medicine holds enormous promise, but much of that promise is lost in translation, muddied by outdated practices and fragmented delivery models. In many clinics today, the process is split across multiple third-party labs; one handles cell collection, another manages culturing, a third oversees storage. Somewhere along the line, testing and transport happen, too. By the time those cells make it back to the patient, their therapeutic potential is often diminished, damaged in transit, degraded by delays or compromised by inconsistent protocols. Yet they’re still administered as though they carry full clinical benefit. BioXcellerator is reshaping that reality. Rather than relying on a patchwork of vendors, BioXcellerator has built a fully integrated regenerative medicine platform. Every stage of the process, cell sourcing, culturing, expansion and clinical delivery happens under one roof. That vertical integration enables complete oversight, ensuring what is delivered to the patient has verified purity, potency and viability. Just as importantly, the company doesn’t follow the status quo. Many clinics in the U.S. continue to use a patient’s own bone marrow or adipose tissue to extract stem cells, largely because these methods fall within existing FDA exemptions. But these cells tend to be older, less active and limited in regenerative capacity. BioXcellerator takes a different approach. The company uses donor-derived mesenchymal stem cells (MSC) sourced exclusively from Wharton’s Jelly, the most regenerative portion of umbilical cord tissue. These cells are younger, more biologically active and collected through ethically sound, non-invasive procedures. “We’re offering a stem cell therapy that delivers what the field has long been asking for: a consistent, evidence-based approach to cell therapy. There’s no guesswork, just measurable outcomes patients and practitioners can trust,” says Eric Stoffers, founder and CEO. Each treatment begins with a careful protocol of selecting qualified donors, purifying and expanding the cells, and rigorously testing for safety and potency. What sets the process apart is how the cells are cultured—in a low-oxygen or hypoxic environment that mimics the conditions of the human body during healing. That subtle shift makes a big difference, boosting the cells’ ability to reduce inflammation and repair damaged tissue, from nerves and cartilage to bone..
Bioprocessing
Translating laboratory research into life-saving solutions requires clinically relevant samples and expert guidance. But many researchers struggle to find high-quality, well-matched tissue specimens. Without the right pathology insight or complete clinical data, lab tests can fail, costs can rise and research timelines can be delayed. Cutting Edge Biomed, a pathologist-run, pathology-ycentric CRO, ensures every biospecimen is expertly selected, reviewed and processed with the clinical expertise needed for translational success. It offers a biorepository of de-identified formalin-fixed, paraffin-embedded (FFPE) tissues and tissue-associated data vetted for quality and accuracy, to ensure all biospecimens are standardized, well-fixed, and well preserved, enabling research outcomes to be robust, accurate, reliable, reproducible and meaningful. In addition to its biorepository, Cutting Edge Biomed provides histopathology, consulting and medical writing services, including study design guidance and support for IRB applications. This ability to meet specialized research needs across oncology, genomics and molecular diagnostics has made Cutting Edge Biomed a preferred partner for leading academic institutions, biotech firms and pharmaceutical companies worldwide. “We are driven not by profit, but by a passion and commitment to help accelerate discovery and development that will bring new and improved diagnostic tests, prognostic indicators, risk assessment tools, therapies and devices to market sooner for improved patient outcomes. We believe it is our obligation as healthcare providers to support medical research. In this way we care not only for our patients today, but for generations of patients to follow. There is no greater or broader patient advocacy,” says Sharon Mair, chief scientific advisor. Mair’s deep industry expertise drives the company’s mission and sets the tone for service excellence. With over two decades of experience in clinical research and frontline pathology practice, she understands the needs and challenges on both sides of the bench-to-bedside continuum. This leadership perspective shapes Cutting Edge Biomed’s steadfast commitment to expert oversight. The team offers free consultations to guide clients in selecting the right FFPE tissue blocks to achieve their research goals. These discussions help ensure that specimen choices align with regulatory expectations and avoid downstream issues, such as complications during FDA approval. Every project undergoes pathologist review before processing and shipment. Cutting Edge Biomed takes a thorough approach long before a quote is issued. While procuring all tissues exclusively from North America upholds high standards, the team invests the time upfront to ensure that every case meets the precise inclusion and exclusion criteria set by the client. For example, when a researcher requests ten breast cancer cases with specific requirements, the team conducts a full pathologist review. It performs internal QC checks on each case to verify scientific fit and sample integrity..
Clinical Trial
Finding promising treatments through clinical trials offers renewed hope to patients and families. With the right support, the path to these opportunities becomes faster, clearer, and more accessible. Carebox helps patients discover relevant, potentially life-changing treatment options available only in clinical trials. In parallel, its customers – including pharmaceutical companies sponsoring trials, research centers / hospitals conducting them, and patient advocacy groups guiding patients through their journeys – gain from enhanced enrollment while promoting diversity and patient-centricity. “It’s a win-win for our pharma company customers and the patients they serve. By helping patients access the right treatment options in clinical trials, we help trial sponsors and research sites achieve their clinical trial enrollment goals,” says Brian Weiss, CEO. At the core of this effort is Carebox Connect, a modular, turnkey SaaS platform which addresses the most pressing challenges patients and caregivers face: identifying which clinical trials are relevant to their unique medical circumstances. In public registries, clinical trial eligibility criteria can only be reviewed one study at a time. There is no way to identify which studies are relevant to a patient’s specific condition, treatment history, and disease stage. Carebox’s unique ConditionMatch capability allows patients or family members to answer five to ten questions about their condition, treatment history, and personal characteristics related to their illness. Using this information, the platform identifies trials for which the patient is potentially eligible to participate. Next, a small number of more detailed questions associated with the identified trials further pinpoint relevant trials and ensure the patient is properly pre-qualified to be referred to a trial site. ConditionMatch thus simultaneously serves two functions: it identifies potentially relevant trials for patients, and it pre-screens for any such trial that is selected..
Life Science Consulting
Do No Harm
Jim Cook, Senior Director, System Laboratory Services, Houston Methodist
Life Science Testing
The Cancer Immunotherapy Treatment Paradigm
Charles G. Drake, M.D., Ph.D., Vice President, Immuno-Oncology, the Janssen Pharmaceutical Companies of Johnson & Johnson
Drug Discovery and Development
Accelerating Early-Stage Drug Development
Safwan Kezbor, M.D., Executive Medical Director, Global Clinical Development, Shionogi Inc
Clinical Laboratory
Helpful Considerations When Selecting New Laboratory Instrumentation
Stephanie Whitehead, Vice President, Pathology Services, University Health
Life Science Consulting
Embracing Technology And Future Of Clinical Trial
Carrie Lewis, Executive Director and Clinical Program Optimization, Endo International
Antibodies
The Impact of AI on FP&A in the Life Sciences Sector
Lina Parra Cartagena, Associate Director of Finance - Operations, Vertex Pharmaceuticals
Life Science Consulting
Precision Oncology Initiatives To Catalyze Personalized Cancer Care
Valsamo Anagnostou, Alex Grass Professor of Oncology, The Johns Hopkins University School of Medicine
Life Science Consulting
Navigating Leadership and Innovation in Radiology
Ryan Garland MHA, AVP- South Region Radiology & Respiratory, Endeavor Health
Life Science Testing
Leadership And Innovation In Laboratory Services Insights
Tyler Giess, Director of Laboratory Services, Washington Regional
Antibodies
Leading-Edge Labs: A Blueprint For Exceptional Patient Care
Ancel R. Nelson, Laboratory Director, York Hospital
Life Science Testing
Recent Advances in Multispecific Antibody and Antibody Drug Conjugate Platforms: Approvals, Advantages, Challenges and Future Directions
Hong Ma, M.D., M.S., M.B.A, Chief Clinical Development Officer, Oricell Therapeutics
Life Science Testing
Cell Therapies: Here comes the next wave!
Robert Richards, Corporate Director of the Center for Cell Therapy and Transplant, Penn Medicine, University of Pennsylvania Health System
Genomics
Innovating Pediatric Healthcare with Genomics
Dr. Catherine Brownstein, Manager, Molecular Genomics Core Facility, Boston Children’s Hospital
IN MY OPINION
Contract Manufacturing
Charting a Trailblazing Path in Clinical Development
Maribelle Guloy, Director of Clinical Development, American Regent, Inc.
LAST WORD
Antibodies
Accelerating Digital Transformation through an Agile, Customer-centric Approach
Mark Mintz, Chief Information Officer, Charles River Laboratories
IN FOCUS
Laboratories in the Age of AI and Advanced Diagnostics
Laboratory science is evolving through automation, IoT, AI, and sustainability, enhancing precision and efficiency while driving significant advancements in research and diagnostics.
AI-Powered Genomic Profiling and Its Impact on Therapy and Trials
The integration of AI with genomic profiling revolutionizes precision medicine by enhancing therapy selection and clinical trial design, leading to more tailored treatments and improved patient outcomes through advanced data analysis.
EDITORIAL
Unlocking the Future of Life Sciences
Laboratories are adopting modular automation platforms and cloud-integrated lab information management systems to streamline workflows and increase data traceability. AI-driven robotics is enabling real-time experiment tracking, sample processing and inventory management with minimal human intervention.
Personalized cancer therapies are being revolutionized by multi-omic data integration and AI models that predict patient response to treatments. Advanced liquid biopsy technologies are enabling earlier detection and monitoring through minimally invasive sampling and high-sensitivity biomarker analysis.
AI is accelerating life science discovery by decoding protein structures, predicting drug interactions, and automating research workflows. Generative AI models are being used to design novel compounds, simulate biological pathways, and reduce time-to-market for new therapies.
This edition of Life Sciences Review brings recent developments in the field and insights into how organizations can adapt to these disruptive trends to deliver transformative guest experiences.
It features thought leadership articles from industry experts, including Maribelle Guloy, director of clinical development at American Regent, Inc, who discusses a trailblazing path in clinical development. Safwan Kezbor, M.D., global medical lead (senior medical director), clinical development at Shionogi Inc, shares his insights into accelerating early-stage drug development.
It also features Alliant Lab Consulting, a specialized laboratory consulting firm delivering end-to-end validation, quality management and operational support for clinical and physician office laboratories.
We hope this edition featuring the Laboratory Innovation Solutions, Next-generation Oncology, Pathology Lab Design And Build Out Services, Stem Cell Therapy, Clinical Trial Matching Platform, Antibody Labeling Solution, Life Sciences AI in 2025 helps you build the partnership your organization needs to sharpen its competitive edge in the life science industry.
